This invention relates to an improved therapy for treating patients having melanoma after definitive surgical removal of the lesions by administering a therapeutically effective dose of pegylated interferon-alpha for a time sufficient to increase progression-free survival time.
Melanoma incidence is increasing at a rate that exceeds all that for other solid tumors. Patients with primary melanoma of greater than 4 mm or metastatic melanoma involving regional lymph nodes possess a 50 to 90% mortality risk following surgical excision of the primary melanomas.
Recently, the Eastern Cooperative Oncology Group (“ECOG”) published results of the use of interferon alpha-2b in patients with stage III cutaneous melanoma as adjuvant therapy following surgery for deep primary (T4) or regionally metastatic (N1) melanoma (Kirkwood, J. M., et al. J. Clin. Oncol., Vol 14: (1996) pages 4-17.) The interferon alpha-2b therapy used by ECOG involved an induction phase of 20 million IU of interferon alpha-2b per square meter of body surface area (m2) administered intravenously (“IV”) daily for five days every week for four weeks followed by maintenance interferon alpha therapy of 10 million IU/M2 administered subcutaneously (“SC”) three times a week (“TIW”) for 48 weeks. A significant improvement in median disease-free survival and overall survival were observed versus control (observation) despite dosage reductions or delays for toxicity in 50% of the patients during the IV induction therapy phase and in 48% of the patients in the SC maintenance phase. Hematologic, neurologic and constitutional toxicities occurred among these patients requiring dose reduction or withdrawal from the interferon alpha therapy. Subject compliance with the dosage and dosage regimen during both phases is considered to be important to achieve maximum clinical benefit. Accordingly, there is a need for improved therapy for treating patients having melanoma with higher patient compliance.